[关键词]
[摘要]
2020年初始新型冠状病毒肺炎(COVID-19)疫情爆发,国家经济和人民生活受到重创,临床试验行业深受影响,也给研究机构管理和试验项目实施带来前所未有的挑战。通过分析各大研究机构针对COVID-19防控要求下的应对措施,选取2020年1月23日至2020年4月8日,整理出本研究中心试验进展情况、处理方式、随访用药、脱落失访等情况,探讨疫情期间降低临床试验影响的可行性方法,旨在为今后探索临床试验的远程执行积累经验,为建立特殊时期临床试验应对策略提供参考依据。
[Key word]
[Abstract]
At the beginning of 2020, with the outbreak of the nationspread coronavirus pneumonia (COVID-19), the national economy and people's lives have been deeply affected, as well as the clinical trial industry, which has brought unprecedented challenges to the management of research institutions and the implementation of clinical trial projects. This study analyzes the measures of chinese major research institutions in response to the requirements of the prevention and control of new coronavirus pneumonia. We select 76-day of 2020.01.23-2020.04.08 as time frame, to sum up the ongoing projects, treatment methods, followup medications, and loss of follow-ups of our research center, and aim to explore the feasibility of reducing the impact of clinical trials during the epidemic, as well as to accumulate experience for the remote execution of clinical trials in the future, and provide a reference for establishing relevant strategy for clinical trials under a special circumstance.
[中图分类号]
[基金项目]